Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Proportion of participants for whom SmartMatch generates at least one actionable treatment recommendation that is presented at the PMTB within 4 weeks (≤ 28 days) of fresh tissue acquisition
Study Overview
Brief Summary
This study is being done to determine how easy it is to use standard of care (SOC) surgical resections or biopsy for SmartMatch analysis to determine treatment options in advanced gynecological malignancies.
Detailed Description
OUTLINE: This is an observational study.
Patients undergo tissue sample collection obtained from standard of care surgical resection or biopsy for SmartMatch laboratory analysis and have their medical records reviewed on study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Histologically confirmed rare gynecologic malignancy, including but not limited to those listed
- •Metastatic or unresectable disease, OR disease for which additional systemic therapy is indicated
- •Fresh tumor tissue available from a SOC surgical procedure or biopsy that in the judgment of the treating team will yield adequate viable tumor for SmartMatch analysis
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate organ function to receive systemic therapy as determined by the treating oncologist (protocol does not specify thresholds because therapy is not mandated)
- •Ability to understand and willingness to sign informed consent
- •Willingness to allow data abstraction from the electronic health record for study endpoints
Exclusion Criteria
- •Lack of tumor tissue suitable for SmartMatch analysis
- •Purely borderline tumors or benign ovarian/uterine neoplasms
- •Any condition that, in the opinion of the treating oncologist or PI, would interfere with receiving systemic therapy
- •Inability to provide informed consent or comply with study procedures
Arms & Interventions
Observational - SmartMatch laboratory analysis
Patients undergo tissue sample collection obtained from standard of care surgical resection or biopsy for SmartMatch laboratory analysis and have their medical records reviewed on study.
Outcomes
Primary Outcomes
Proportion of participants for whom SmartMatch generates at least one actionable treatment recommendation that is presented at the PMTB within 4 weeks (≤ 28 days) of fresh tissue acquisition
Time Frame: From enrollment up to 36 months
An actionable recommendation is defined as: 1. FDA-approved therapy for any indication or available clinical trial; 2. Predicted to have activity by SmartMatch functional precision medicine (FPM) and/or genomics; 3. Endorsed by PMTB as clinically reasonable.
Secondary Outcomes
- Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained(Up to 36 months)
- Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy(Up to 36 months)
- Implementation Feasibility: Time from live tissue collection to SmartMatch report(Up to 36 months)
- Implementation Feasibility: Reasons for access failure/delay (insurance denial, clinical decline, etc.)(Up to 36 months)
- Proportion of patients achieving growth modulation index (GMI) ≥ 1.3(Up to 36 months)
- Proportion of patients achieving progression-free survival on matched therapy (PFSmatched)(Up to 36 months)
- Proportion of patients achieving progression-free survival on the prior line of therapy (PFSpast)(Up to 36 months)
- Proportion of patients achieving GMI = PFSmatched / PFSpast(Up to 36 months)
- Proportion of patients who begin identified treatment pathways following Precision Medicine Tumor Board (PMTB) review(Up to 36 months)